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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR INDEFLATOR PPAK 20/30; ACCESSORIES

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ABBOTT VASCULAR INDEFLATOR PPAK 20/30; ACCESSORIES Back to Search Results
Model Number 1003327
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was to treat mildly calcified, mildly tortuous left anterior descending (lad) coronary artery.The lesion was going to be pre-dilated and the indeflator was connected to the balloon dilatation catheter (bdc).During inflation, the display of the indeflator was delayed in showing the pressure measurement.The device was replaced with a new indeflator and the procedure was successfully completed.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported break gauge was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As the reported difficulties were unable to be confirmed during return analysis, the investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
INDEFLATOR PPAK 20/30
Type of Device
ACCESSORIES
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11068382
MDR Text Key223615312
Report Number2024168-2020-10919
Device Sequence Number1
Product Code MAV
UDI-Device Identifier08717648013973
UDI-Public08717648013973
Combination Product (y/n)N
PMA/PMN Number
K961471
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Model Number1003327
Device Catalogue Number1003327
Device Lot Number60250002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received01/11/2021
Supplement Dates FDA Received01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
2.0X15 BALLOON CATHETER
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